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510(k) Data Aggregation

    K Number
    K024081
    Device Name
    DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
    Manufacturer
    SAFEHEALTH MEDICAL SUPPLY CORP.
    Date Cleared
    2003-01-28

    (48 days)

    Product Code
    LYZ
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

    Device Description

    DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria.

    The document is a letter from the FDA to a medical device manufacturer, stating that their "Disposable Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green Color" have been found substantially equivalent to legally marketed predicate devices. It discusses regulatory requirements for marketing the device.

    Therefore, I cannot provide the requested information about acceptance criteria and a study to prove they are met based on this text.

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